CVS dye-free childrens allergy

Product NDC
51316-710
11-digit product format
513160710
Labeler code
51316
Product ID
51316-710_483f1ed8-8525-4f47-a6c7-01bb4f8fc338
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
CVS PHARMACY
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-22
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
CVS dye-free childrens allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049906Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
db5a5eff-1bb1-4d00-8c01-caae7a1c7223Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-710-08CVS dye-free childrens allergy1 in 1 CARTONSYRUP15
51316-710-08CVS dye-free childrens allergy236 mL in 1 BOTTLE, PLASTICSYRUP2365

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-710CVS DYE-FREE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [CVS PHARMACY]4Current NDC, Legacy NDC, 2 package rows20240822_db5a5eff-1bb1-4d00-8c01-caae7a1c7223.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 34 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids AllergyDIPHENHYDRAMINE HCLGenexa Inc.a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec42026-05-08WarningsExact identifier
application number: M012
day time non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Incf4fd597f-bca2-4ed4-b353-6c734f2f885c2026-05-08WarningsExact identifier
application number: M012
Daytime Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacyd8339bb0-5da3-4f34-a819-339643cf4a972026-05-08WarningsExact identifier
application number: M012
severe tussin cfACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDa26afc33-533e-4dc0-ab25-21be87356e222026-05-08WarningsExact identifier
application number: M012
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketcdd53eba-1fa2-49c1-b03d-c32f309da7fb2026-05-08WarningsExact identifier
application number: M012
Benadryl Allergy Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCbfeae100-e2d1-4607-be3b-2d9b15cd4f7f2026-05-07WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLH E B6503761f-37ae-4f39-b727-cb75d4c4a3c92026-05-07Warnings, Adverse reactionsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLCad199488-a4be-4b6e-b806-67ce8a6e907e2026-05-07WarningsExact identifier
application number: M012
good sense nasalOXYMETAZOLINE HCLL. Perrigo Company5d42adb9-3625-4072-a6b1-29a229f255c82026-05-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company4856cd7b-ccdf-4546-9c65-236ebaac3dca2026-05-06WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac2026-05-06WarningsExact identifier
application number: M012
daytime cough and chest congestion dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED175cc2d0-0202-4e38-8af2-9fc126b7412d2026-05-06WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals90fae0fa-da07-4ea8-bdbd-39c2ed99ae592026-05-06WarningsExact identifier
application number: M012
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals5d8b980f-0011-41e3-a881-ad10fe3990792026-05-06WarningsExact identifier
application number: M012
HALLS MentholyptusMENTHOLMondelez Global LLC38d12374-e2c7-444c-e063-6294a90a42b32026-05-06WarningsExact identifier
application number: M012
HALLS MentholyptusMENTHOLMondelez Global LLC1ab295ff-94b1-c938-e063-6294a90a98fd2026-05-06WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.512af63d-2f09-4baa-e063-6394a90a86bd2026-05-06WarningsExact identifier
application number: M012
Thieves Chest RubCHEST RUBYoung Living Essential Oils, LC.9b7f125e-6caa-c53e-e053-2a95a90a737e2026-05-06WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Plus Pain and HeadacheACETAMINOPHEN, GUAIFENESINShield Pharmaceuticals Corpf20c0db1-dcf3-4bfc-b3e4-930398f82dc92026-05-06WarningsExact identifier
application number: M012
NitetimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc8aa6492b-1723-4c6b-82ee-4f800301c6ad2026-05-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNdb5a5eff-1bb1-4d00-8c01-caae7a1c72235
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDdb5a5eff-1bb1-4d00-8c01-caae7a1c72235
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYdb5a5eff-1bb1-4d00-8c01-caae7a1c72235
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYdb5a5eff-1bb1-4d00-8c01-caae7a1c72235
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYdb5a5eff-1bb1-4d00-8c01-caae7a1c72235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51316-710-08513160710081 BOTTLE, PLASTIC in 1 CARTON (51316-710-08) / 236 mL in 1 BOTTLE, PLASTIC2022-07-220000-00-00NoNoCurrent